A surgical team at The Methodist Hospital in Houston injected stem cells into the beating heart of a patient with advanced heart failure today. Heart surgeon Dr. Michael Reardon, second from left, and Dr. Brian Bruckner, fourth from right, led the procedure, which was the first of its kind in the United States. Stem cells from the patient's bone marrow are in the syringe in the foreground. Photo Credit: The Mthodist Hospital, HoustonNovember 20, 2008, (Sawf News) - Following the initial positive experience in Germany, the promising cardiac regeneration treatment has been tried for the first time in the US. Surgeons at The Methodist Hospital in Houston injected highly-concentrated stem cells directly into a patient’s damaged heart.
In an investigational study of new heart failure treatments, Aastrom's CRCs (Cardiac Repair Cells) technique may be more effective in regenerating healthy heart tissue in the treatment of dilated cardiomyopathy (DCM) than current methods that use a catheter to put standard stem cells through the bloodstream into the heart.
Surgeons from The Methodist Hospital in Houston inject stem cells into a patient's heart. They hope the stem cells, taken from the patient's bone marrow, will improve his heart's ability to pump effectively. Photo Credit: Erin Fairchild, The Mthodist Hospital, HoustonThe 58-year-old veteran and businessman is resting comfortably and is expected to be discharged this weekend.
“Some patients have such severe heart failure that their only current option is a heart transplant,” said Dr. Brian Bruckner, cardiac surgeon at the Methodist DeBakey Heart & Vascular Center in Houston. “We hope that stem cells will stimulate angiogenesis, the growth of new blood vessels, restore mechanical function in diseased heart tissue, and return patients to a much better quality of life without a transplant.”
In a novel process, the patient’s strongest and most robust stem and progenitor cells, derived from the patient’s own bone marrow, are amplified up to 1,000 times before they’re injected back into the patient’s heart. In the procedure, Dr. Bruckner made a small incision in the left side of the patient’s chest and administered approximately 25 injections of concentrated stem cells into the patient’s heart. All patients in the trial will be followed for 12 months after the injections.
There are currently 5.5 million people in the U.S. suffering from chronic heart failure. A subset of these patients has dilated cardiomyopathy (DCM), a chronic heart disease in which the patient's heart can not pump effectively enough to deliver blood and oxygen to the vital organs in the body. Patients with DCM typically experience severe limitations to physical activity and shortness of breath.
“Without a new approach to treatment of these patients, they will continue to decline and less than 40 percent will survive five years,” said Bruckner, principal investigator for the trial. “We hope this trial will provide a completely new and viable treatment for them.”
About the trial The IMPACT-DCM trial is a randomized, controlled, prospective, open-label, Phase II study that will seek to enroll 20 patients with ischemic dilated cardiomyopathy (DCM) and 20 patients with non-ischemic DCM at five clinical sites in the U.S. The trial is sponsored by Aastrom Biosciences, Inc.
Participants must have a left ventricular ejection fraction of less than or equal to 30 percent (60-75 percent is typical for a healthy person) and meet certain other eligibility criteria.
All patients in each group will receive standard medical care and 75 percent of the patients will be treated with cardiac repair cells (CRC), a mixture of stem cells and progenitor cells derived from the patient’s own blood marrow, through direct injection into the heart muscle during a minimally-invasive procedure in the operating room.
While the primary objective of this study is to assess the safety of CRCs in patients with DCM, efficacy measures including left ventricular ejection fraction and other cardiac function parameters as well as heart failure stage will be monitored. Patients will be followed for 12 months post treatment.
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